510(k) Report

FDA applicant

Telectronics Pacing Systems, Inc.

Englewood, CO22 decisions1983–19970 recalls

FDA records 22 decisions for Telectronics Pacing Systems, Inc. (Englewood, CO) from 1983 to 1997: 20 510(k) clearances and 2 original PMA approvals. Most are in product codes DTB (Permanent Pacemaker Electrode) and DTD (Pacemaker Lead Adaptor). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Telectronics Pacing Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Telectronics Pacing Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Telectronics Pacing Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Telectronics”

FDA records each applicant name separately; these may or may not be the same firm.